Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

March 22, 2023

Primary Completion Date

September 10, 2025

Study Completion Date

February 17, 2026

Conditions
Polymyalgia Rheumatica
Interventions
DRUG

Secukinumab 300 mg

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

DRUG

Secukinumab 150 mg

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

OTHER

Placebo to secukinumab

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Trial Locations (134)

1027

Novartis Investigative Site, Budapest

1708

Novartis Investigative Site, Fribourg

2150

Novartis Investigative Site, Parramatta

3000

Novartis Investigative Site, Leuven

3081

Novartis Investigative Site, Heidelberg Heights

4000

Novartis Investigative Site, Liège

4031

Novartis Investigative Site, Basel

4215

Novartis Investigative Site, Southport

6700

Novartis Investigative Site, Esbjerg

6720

Novartis Investigative Site, Szeged

7405

Novartis Investigative Site, Cape Town

7500

Novartis Investigative Site, Panorama

7600

Novartis Investigative Site, Stellenbosch

8000

Novartis Investigative Site, Bruges

8200

Novartis Investigative Site, Aarhus N

Novartis Investigative Site, Veszprém

9007

Novartis Investigative Site, Sankt Gallen

9362

Novartis Investigative Site, Gandrup

13125

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

13616

Novartis Investigative Site, Aix-en-Provence

15006

Novartis Investigative Site, A Coruña

20100

Novartis Investigative Site, Milan

20132

Novartis Investigative Site, Milan

20157

Novartis Investigative Site, Milan

21034

Novartis Investigative Site, Dijon

21740

Klein and Associates, Hagerstown

24768

Novartis Investigative Site, Rendsburg

27100

Novartis Investigative Site, Pavia

28009

Novartis Investigative Site, Madrid

29200

Novartis Investigative Site, Brest

30501

Southeastern Rheumatology Alliance, Gainesville

31059

Novartis Investigative Site, Toulouse

32610

UF Health Cancer Center, Gainesville

33321

West Broward Rheumatology Associates Inc, Tamarac

33486

Rheumatology Associates of South Florida, Boca Raton

34239

Sarasota Arthritis Res Ctr, Sarasota

34295

Novartis Investigative Site, Montpellier

39100

Novartis Investigative Site, Bolzano

40878

Novartis Investigative Site, Ratingen

41013

Novartis Investigative Site, Seville

42123

Novartis Investigative Site, Reggio Emilia

44093

Novartis Investigative Site, Nantes

44130

Paramount Med Rsrch and Consult LLC, Middleburg Heights

44649

Novartis Investigative Site, Herne

44650

Novartis Investigative Site, Guadalajara

46010

Novartis Investigative Site, Valencia

48013

Novartis Investigative Site, Bilbao

48081

Clinical Research Inst of MI, Saint Clair Shores

49325

Novartis Investigative Site, Cholet

51092

Novartis Investigative Site, Reims

64111

Kansas City Physician Partners, Kansas City

67000

Novartis Investigative Site, Strasbourg

68024

Novartis Investigative Site, Colmar

72000

Novartis Investigative Site, Le Mans

77054

Prolato Clinical Research Center, Houston

77070

DM Clinical Research, Houston

77382

Advanced Rheumatology of Houston, Spring

78229

Accurate Clinical Research Inc, San Antonio

79106

Novartis Investigative Site, Freiburg im Breisgau

83800

Novartis Investigative Site, Toulon

85032

AZ Arthritis and Rheumtlgy Rsh PLLC, Phoenix

85381

Sun Valley Arthritis Center Ltd, Peoria

85392

Arizona Arthritis and Rheumatology Associates PLLC, Avondale

87000

Novartis Investigative Site, Limoges

90404

Providence Saint Johns Health Ctr, Santa Monica

91056

Novartis Investigative Site, Erlangen

91307

Center for Rheumatology Research, West Hills

91361

Millennium Clinical Trials, Westlake Village

94578

Precn Comprehensive Clnl Rsch Solns, San Leandro

97080

Novartis Investigative Site, Würzburg

110221

Novartis Investigative Site, Bogotá

166830

Novartis Investigative Site, Beirut

760042

Novartis Investigative Site, Santiago de Cali

2531172

Novartis Investigative Site, Viña del Mar

5265601

Novartis Investigative Site, Ramat Gan

6423906

Novartis Investigative Site, Tel Aviv

7500571

Novartis Investigative Site, Santiago

8380465

Novartis Investigative Site, Santiago

8420383

Novartis Investigative Site, Santiago

02114

Massachusetts General Hospital, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

B1878GEG

Novartis Investigative Site, Quilmes

C1055AAF

Novartis Investigative Site, Buenos Aires

C1119ACN

Novartis Investigative Site, Buenos Aires

90480-000

Novartis Investigative Site, Porto Alegre

04038-002

Novartis Investigative Site, São Paulo

01409-902

Novartis Investigative Site, São Paulo

G1V 3M7

Novartis Investigative Site, Québec

080002

Novartis Investigative Site, Barranquilla

080020

Novartis Investigative Site, Barranquilla

140 00

Novartis Investigative Site, Prague

Novartis Investigative Site, Prague

638 00

Novartis Investigative Site, Brno

748 01

Novartis Investigative Site, Hlučín

128 00

Novartis Investigative Site, Prague

686 01

Novartis Investigative Site, Uherské Hradiště

760 01

Novartis Investigative Site, Zlín

DK-7100

Novartis Investigative Site, Vejle

01307

Novartis Investigative Site, Dresden

IS-101

Novartis Investigative Site, Reykjavik

D03 VX82

Novartis Investigative Site, Dublin

06129

Novartis Investigative Site, Perugia

272 8516

Novartis Investigative Site, Ichikawa

814 0180

Novartis Investigative Site, Fukuoka

070-8644

Novartis Investigative Site, Asahikawa

761-0793

Novartis Investigative Site, Kita-gun

252-0392

Novartis Investigative Site, Sagamihara

222-0036

Novartis Investigative Site, Yokohama

380-8582

Novartis Investigative Site, Nagano

874-0011

Novartis Investigative Site, Beppu

586-8521

Novartis Investigative Site, Kawachi-Nagano

550-0006

Novartis Investigative Site, Osaka

113-8431

Novartis Investigative Site, Bunkyo Ku

183-8524

Novartis Investigative Site, Fuchū

198-0042

Novartis Investigative Site, Ōme

750-0041

Novartis Investigative Site, Shimonoseki

409-3898

Novartis Investigative Site, Chūō

700-8607

Novartis Investigative Site, Okayama

534-0021

Novartis Investigative Site, Osaka

7609 PP

Novartis Investigative Site, Almelo

3079 DZ

Novartis Investigative Site, Rotterdam

9713 GZ

Novartis Investigative Site, Groningen

41 902

Novartis Investigative Site, Bytom

20-607

Novartis Investigative Site, Lublin

02 118

Novartis Investigative Site, Warsaw

02 637

Novartis Investigative Site, Warsaw

02-665

Novartis Investigative Site, Warsaw

08208

Novartis Investigative Site, Sabadell

08041

Novartis Investigative Site, Barcelona

113 65

Novartis Investigative Site, Stockholm

EN5 3DJ

Novartis Investigative Site, Barnet

HU3 2RW

Novartis Investigative Site, Hull

WV10 0QP

Novartis Investigative Site, Wolverhampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY